Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

PHASE1RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

May 21, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2029

Conditions
B-cell Acute Lymphoblastic Leukemia
Interventions
DRUG

Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone

"Subjects will receive a course of inotuzumab ozogamicin administered by central venous catheter over 60 minutes on days 1, 8, and 15.~Venetoclax (by mouth or NG) and dexamethasone (by mouth, NG, or IV) are given daily per assigned dose level. Venetoclax and dexamethasone are started 2 days prior to inotuzumab to limit risk of tumor lysis syndrome with a two-day venetoclax ramp up in cycle 1. On days 1 and 8, venetoclax administration should be scheduled for 4 hours after the beginning of inotuzumab ozogamicin administration. If the patient is not able to ingest venetoclax at the scheduled time, it may still be given later in the day, but efforts should be made to administer the venetoclax within 2 hours of the scheduled time whenever possible."

Trial Locations (1)

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT06863259 - Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL | Biotech Hunter | Biotech Hunter